Unique ID issued by UMIN | UMIN000049746 |
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Receipt number | R000056577 |
Scientific Title | A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients |
Date of disclosure of the study information | 2022/12/12 |
Last modified on | 2024/03/18 17:54:39 |
A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients
SMART PRO trial
A Confirmatory Clinical Trial of Two-fractionated Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Prostate Cancer Patients
SMART PRO trial
Japan |
Prostate cancer
Radiology |
Malignancy
NO
To evaluate the safety and efficacy of stereotactic radiotherapy with MR linear accelerators with the dose of 26 Gy/2 fractions for very low/low/intermediate risk prostate cancer patients in NCCN risk classification
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Acute genitourinary adverse events of grade 2 or higher
Other acute adverse event rates, 5-year rate of radiotherapy-related late adverse events (91 days or later after radiotherapy initiation), PSA nadir after radiotherapy completion, 5-year PSA recurrence-free rate, 5-year clinical progression-free rate, 5-year disease-specific survival rate, 5-year distant metastasis-free survival rate, 5-year overall survival rate, PSA recurrence-free period, clinical progression-free period, disease-specific survival, overall survival, patient-reported outcomes, and health economic evaluation using the EQ-5D.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Ultrahypofractionated stereotactic radiotherapy of 26 Gy in 2 fractions in 1-2 weeks using MR linear accelerator
18 | years-old | <= |
80 | years-old | > |
Male
1) Histopatholologically confirmed prostate cancer.
2) Clinical stage of T1c-2cN0M0.
3) Any PSA level measured prior to enrollment is less than 20 ng/ml.
4) Gleason score of 6-7.
5) Very low/low risk or intermediate risk by NCCN guideline risk classification (2022 edition).
6) Patients with or without measurable disease.
7) Age of 18 years or older, and less than 80 years on the date of enrollment.
8) ECOG Performance status (PS) is 0 to 1.
9) No previous surgical treatment of the prostate (transurethral resection of the prostate, prostatic capsulotomy, orchiectomy, etc.), HIFU (high-intensity focused ultrasound), or chemotherapy other than hormone therapy.
10) International Prostate Symptom Score (IPSS) of 19 or less within 28 days prior to enrollment (same day of the week 4 weeks prior to enrollment is acceptable).
11) SpaceOAR is implanted in the rectal wall/prostate rather than in the Denovier space. SpaceOAR is implanted in the rectal wall/prostate, not in the Denovier space, and there is no significant worsening of urinary symptoms after implantation.
12) No prior radiation therapy within the presumable irradiation area in the present clinical trial, including treatment for other types of cancer.
13) No hormone-refractory tumors.
14) Written consent to participate in the study has been obtained from the patient.
15) The patient has been informed of other treatment options and is willing to undergo the study treatment.
1) Patients have an infectious disease requiring systemic treatment.
2) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
3) Patients with diabetes mellitus that is poorly controlled despite continuous use of insulin or oral hypoglycemic agents.
4) Patient has inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
5) Patient has undergone surgery in the abdominopelvic region, excluding appendicectomy and inguinal hernia.
6) Patient has active scleroderma or systemic lupus erythematosus.
7) Is considered by the investigator to be unsuitable for participation in this study.
8) Is taking anticoagulant or antiplatelet medication.
58
1st name | Hiroshi |
Middle name | |
Last name | Igaki |
National Cancer Center Hospital
Depaertment of Radiation Oncology
104-0045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
hirigaki@ncc.go.jp
1st name | Tairo |
Middle name | |
Last name | Kashihara |
National Cancer Center Hospital
Depaertment of Radiation Oncology
104-0045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
tkashiha@ncc.go.jp
National Cancer Center
AMED
Japanese Governmental office
National Cancer Center
5-1-1, Tsukiji, Chuo-ku, Tokyo
0335422511
irst@ml.res.ncc.go.jp
NO
2022 | Year | 12 | Month | 12 | Day |
Unpublished
There is no plans to share individual subject data at this time.
There is no plans to share individual subject data at this time.
Open public recruiting
2022 | Year | 10 | Month | 17 | Day |
2022 | Year | 11 | Month | 29 | Day |
2023 | Year | 01 | Month | 01 | Day |
2030 | Year | 09 | Month | 30 | Day |
2022 | Year | 12 | Month | 11 | Day |
2024 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056577
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